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Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program.

Publication ,  Journal Article
Farnier, M; Hovingh, GK; Langslet, G; Dufour, R; Baccara-Dinet, MT; Din-Bell, C; Manvelian, G; Guyton, JR
Published in: Atherosclerosis
November 2018

BACKGROUND AND AIMS: ODYSSEY OLE (open-label extension; NCT01954394) included patients diagnosed with heterozygous familial hypercholesterolemia (HeFH), receiving maximally tolerated statins, who had completed one of four Phase 3 double-blind parent studies (all 18 months' duration), with the aim to assess longer-term safety and efficacy of alirocumab. METHODS: Patients received starting dose alirocumab 75 mg every 2 weeks (Q2W; patients from FH I, FH II, and LONG TERM) or alirocumab 150 mg Q2W (patients from HIGH FH). Low-density lipoprotein cholesterol (LDL-C) levels were blinded to the patient and physician until Week 8; from Week 8, LDL-C levels were communicated to physicians. From Week 12, dose adjustment from 75 to 150 mg Q2W, or vice versa, was possible per physician's clinical judgment according to patient's LDL-C levels. RESULTS: Patients who had received alirocumab (n = 655) compared with placebo (n = 330) in the parent studies exhibited similar rates of treatment-emergent adverse events (TEAEs; 87.3% vs. 83.9%) during OLE (2.5 years median alirocumab exposure). Overall, 33 patients (3.4%) experienced TEAEs leading to permanent treatment discontinuation. At Week 8, alirocumab reduced mean LDL-C by 44.2% (reduction from 151.9 mg/dL at parent study baseline to 84.9 mg/dL); reduction in LDL-C was consistent to Week 96 of OLE. Reductions in lipid parameters were similar regardless of treatment allocation in the parent study. CONCLUSIONS: In patients with HeFH, no unexpected long-term safety concerns were observed with alirocumab compared with previously published data; durability of LDL-C-lowering over 3 years (including 1.5 years of parent trials) was demonstrated.

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Published In

Atherosclerosis

DOI

EISSN

1879-1484

Publication Date

November 2018

Volume

278

Start / End Page

307 / 314

Location

Ireland

Related Subject Headings

  • Patient Safety
  • Middle Aged
  • Male
  • Hyperlipoproteinemia Type II
  • Humans
  • Heterozygote
  • Follow-Up Studies
  • Female
  • Drug Administration Schedule
  • Double-Blind Method
 

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Farnier, M., Hovingh, G. K., Langslet, G., Dufour, R., Baccara-Dinet, M. T., Din-Bell, C., … Guyton, J. R. (2018). Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program. Atherosclerosis, 278, 307–314. https://doi.org/10.1016/j.atherosclerosis.2018.08.036
Farnier, Michel, G Kees Hovingh, Gisle Langslet, Robert Dufour, Marie T. Baccara-Dinet, Chantal Din-Bell, Garen Manvelian, and John R. Guyton. “Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program.Atherosclerosis 278 (November 2018): 307–14. https://doi.org/10.1016/j.atherosclerosis.2018.08.036.
Farnier M, Hovingh GK, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, et al. Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program. Atherosclerosis. 2018 Nov;278:307–14.
Farnier, Michel, et al. “Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program.Atherosclerosis, vol. 278, Nov. 2018, pp. 307–14. Pubmed, doi:10.1016/j.atherosclerosis.2018.08.036.
Farnier M, Hovingh GK, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Guyton JR. Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program. Atherosclerosis. 2018 Nov;278:307–314.
Journal cover image

Published In

Atherosclerosis

DOI

EISSN

1879-1484

Publication Date

November 2018

Volume

278

Start / End Page

307 / 314

Location

Ireland

Related Subject Headings

  • Patient Safety
  • Middle Aged
  • Male
  • Hyperlipoproteinemia Type II
  • Humans
  • Heterozygote
  • Follow-Up Studies
  • Female
  • Drug Administration Schedule
  • Double-Blind Method